A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 220
- 主要终点
- Part B: Change from Baseline in 28-day average seizure frequency
研究概览
简要总结
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
详细描述
This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female participants 18 to 75 years of age at time of consent.
- •Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
- •a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures
- •Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
- •Ability to keep accurate seizure diaries
- •Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total
排除标准
- •History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired consciousness for > 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
- •History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
- •Resection neurosurgery for seizures <4 months prior to the screening visit.
- •Radiosurgery performed <2 years prior to the screening visit.
- •Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.
- •Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator
研究组 & 干预措施
BHV-7000 25 mg Part A
干预措施: BHV-7000 (Drug)
BHV-7000 50 mg Part A
干预措施: BHV-7000 (Drug)
BHV-7000 75 mg Part B
干预措施: BHV-7000 (Drug)
Placebo Part B
干预措施: Placebo (Drug)
Placebo Part A
干预措施: Placebo (Drug)
结局指标
主要结局
Part B: Change from Baseline in 28-day average seizure frequency
时间窗: Baseline, Week 8 to Week 20 of Part B
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.
Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
时间窗: Week 8 to Week 20 of Part A
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
Part A: Number of Participants With Clinically Significant Laboratory Abnormalities
时间窗: Week 8 to Week 20 of Part A
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.
次要结局
- Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month(Baseline, Week 8 to Week 20 of Part B)
- Part B: Change from Baseline in 28-day average seizure frequency during first month of treatment(Baseline, Week 8 to Week 12 of Part B)
- Part B: Percentage of Participants with at at least 75% reduction in seizure frequency per month(Baseline, Week 8 to Week 20 of Part B)
- Part B: Percentage of Participants with seizure freedom during DB Phase(Week 8 to Week 20 of Part B)
- Part B: Change from baseline in 7-day adjusted seizure frequency during first week of treatment(Baseline, Week 8 to Week 9 of Part B)
- Part B: Change from baseline in Patient Global Impression of Change (PGI-C)(Baseline, Week 20 of Part B)
- Part B: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs(Week 8 to Week 20 of Part B)
- Part B: Number of Participants With Clinically Significant Laboratory Abnormalities(Week 8 to Week 20 of Part B)